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    48 views46 pages

    ISO 13485 2016 Medical Devices Quality M

    Uploaded by

    chanelpekas

    Copyright:

    © All Rights Reserved
    Download as PDF or read online from Scribd
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    INTERNATIONAL Iso STANDARD 13485 ‘Third edition 2016-03-01, Medical devices — Quality management systems — Requirements for regulatory purposes Dispositifs médicaux — Systémes de management de la qualité — Exigences @ des fins réglementaires Reference number 180 13485:2016(E) ‘et decent oma e=Sts We de VITALMEX COMERCIAL SA DEY. 6150 2016 god date ISO 13485:2016(E) A COPYRIGHT PROTECTED DOCUMENT {© 180 2016, Published in Switzerland All rights reserved. Unless otherwise specified, no par of this publication may be reproduced or utilized otherwise in any form for by any means, electronic or mechanical, including photocopying, or posting on the internet or an intranet, without prior ‘written permission, Permission can be requested from elther 180 a the address below or ISO's member body n the country of the requester. 180 copyright office (Ch de Blandonnet® + CP401 (CH-1214 Vernier, Geneva, Switzerland ‘Teh v41 22.749001 11 Fax 41 22749 0947 copyright @iso.org wonelso.org ii ‘ite dace foo pare dela tc de VITALMEX COMERCIAL SABER 2016 ~All rights reserved squid hve ISO 13485:2016(E) Contents Page ore ee ence Iptroduct on ae mn e0 — Si te 10s Scope. — 2 Normative references... 3 Termsand definitions... 4 Quality management system... 44 General requirements... 42 — Documentation requirements. 4241 General... 42.2 Quality manual —. aa 4.2.3 Medical device file 4.2.4 Control of documents... 425 Control ofrecords... 5 Management responsibility - 5.1 Management commitment oem (BQ Custer FOR ec 53 Quality policy. 2 a — ~ S41 Quality objectives. S 5.4.2 Quality management system planning —— 5.5 Responsibility, authority and communication. 5.5.1 — Responsibility and authority... anno 55.2 Management representative. ~ 55.3 Internal communication. = 5.6 Management 1eVICW arene 5.6.1 General. : aaa 5.6.2 Review input meen 56.3 Review output 6 Resource management o-ene-ieeneennennnn 6.1 Provision of resources... Ese 6.2 Human resources een — 63 Infrastructure 64 Work environment and contamination control.-—--—-—- Az 64.1 Work environment ener nee 12 64.2 Contamination Control eon Se 12) 7 Product realization

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